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NDC 67234-0007-01 Acne Treatment 5 mg/g Details

Acne Treatment 5 mg/g

Acne Treatment is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Natureplex LLC. The primary component is SALICYLIC ACID.

MedlinePlus Drug Summary

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or birthmarks. Salicylic acid is in a class of medications called keratolytic agents. Topical salicylic acid treats acne by reducing swelling and redness and unplugging blocked skin pores to allow pimples to shrink. It treats other skin conditions by softening and loosening dry, scaly, or thickened skin so that it falls off or can be removed easily.

Related Packages: 67234-0007-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical

Product Information

NDC	67234-0007
Product ID	67234-007_419c92fa-de15-402c-9b8b-f3ae05f0e19a
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Acne Treatment
Proprietary Name Suffix	n/a
Non-Proprietary Name	SALICYLIC ACID
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	5
Active Ingredient Units	mg/g
Substance Name	SALICYLIC ACID
Labeler Name	Natureplex LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333D
Listing Certified Through	2024-12-31

Package

Package Images

NDC 67234-0007-01 (67234000701)

Pricing Information	N/A
NDC Package Code	67234-007-01
Billing NDC	67234000701
Package	1 TUBE in 1 BOX (67234-007-01) / 42 g in 1 TUBE
Marketing Start Date	2007-01-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 31b50718-cc60-460d-aad7-b9620970d411 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid 0.5%

Purpose

Acne Treatment

Use

For the treatment of acne.

Warnings

For external use only.

When using this product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below
clean the skin thoroughly before applying this product
cover entire affected area with a thin layer 1 to 3 times daily
because excessive drying of skin may occur, start with one application daily, and gradually increase to 2 or 3 times daily if needed or as directed by a doctor
if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Other information

store at 15 to 30°C (59 to 86°F)
close cap tightly after use
Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive ingredients

citric acid, sodium phosphate dibasic, DMDM hydantoin, glycerin, hydroxyethylcellulose, isopropyl alcohol, methylparaben, polysorbate-20, propylene glycol, propylparaben, purified water

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 42.5 g Tube Box

Natureplex™

Acne

Treatment

Clear Gel

NET WT. 1.5 Oz.(42.5g)

Principal Display Panel - 42.5 g Tube Box

INGREDIENTS AND APPEARANCE

ACNE TREATMENT

salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67234-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67234-007-01	1 in 1 BOX	01/02/2007
1		42 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	01/02/2007

Labeler - Natureplex LLC (062808196)

Name	Address	ID/FEI	Business Operations
Establishment
Natureplex LLC		062808196	MANUFACTURE(67234-007)

Revised: 8/2019

Document Id: 419c92fa-de15-402c-9b8b-f3ae05f0e19a

Set id: 31b50718-cc60-460d-aad7-b9620970d411

Version: 3

Effective Time: 20190801